Participant flow

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer · Source last updated 2025-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received 5 milligrams (mg) of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

   id

   FG000

   title

   Fruquintinib + Best Supportive Care (BSC) Group

2. description

   Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

   id

   FG001

   title

   Placebo + BSC Group

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         411

      2. group Id

         FG001

         num Subjects

         203

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal of consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      Radiological Disease Progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         14

      type

      Sponsor Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         461

      2. group Id

         FG001

         num Subjects

         230

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         456

      2. group Id

         FG001

         num Subjects

         230

      comment

      The Safety population (SP) included all randomized participants who received at least 1 dose of study drug.

      type

      Safety Population (SP)

   3. achievements

      1. group Id

         FG000

         num Subjects

         329

      2. group Id

         FG001

         num Subjects

         2

      comment

      The Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 post dose PK sample collected and analyzed.

      type

      Pharmacokinetic (PK) Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         461

      2. group Id

         FG001

         num Subjects

         230

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 691 participants were randomized and enrolled in this study.

recruitment Details

The study was conducted at 124 study sites in the United States, Europe region, Japan, and Australia.

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Preserved source evidence · Independent clinical review pending · Not medical advice